Verzenio prescribing guideline recommendations

Expectations of using early breast cancer

Confirmation of efficacy of combined endocrine therapy through monarchE and real world research

Verzenio is expected to be used in early breast cancer patients with a high risk of recurrence even after surgery.

 

Looking at the recently published domestic and international breast cancer treatment guidelines, the CDK4/6 inhibitor Verzenio was recommended based on a high level of evidence as adjuvant therapy after surgery for patients with high-risk recurrence of early breast cancer with HR+/HER2- positive lymph nodes.

 

In the 10th breast cancer treatment recommendation of the Korean Breast Cancer Society revised in April this year, patients who underwent surgery for HR+/HER2- breast cancer had 4 or more lymph node involvement, 1-3 benign lymph nodes, and tumor size of 5 cm or more or a high-risk tumor of grade 3 In order to reduce the recurrence rate of patients with factors, endocrine therapy and Verzenio combination treatment after breast cancer surgery were recommended as 'evidence level 1' and 'recommendation grade A'.

 

Prior to the Korean Breast Cancer Society, the treatment guidelines of the National Comprehensive Cancer Network in the US were also revised in March.

 

NCCN changed the level of evidence for 2 years of Verzenio + endocrine therapy as adjuvant therapy after surgery in HR+/HER2- high-risk breast cancer patients (the details are the same as in Korea) from category 2A to category 1, the highest grade.

 

Verzenio's most recent data is the results of a 4-year follow-up study of monarchE, presented at the San Antonio Breast Cancer Symposium annual conference in December 2022 and published in The Lancet Oncology in January 2023.

 

In the paper, the patient group treated with Verzenio + endocrine therapy had a reduced risk of recurrence and death compared to the control group until the 4th year after completing 2 years of postoperative adjuvant therapy, and the gap with the control group continued to increase until the 4th year.

 

These results suggest the possibility that the risk of recurrence can be continuously reduced by maintaining endocrine therapy after completing Verzenio + endocrine therapy for 2 years.

 

The monarchE study was a phase 3 study that confirmed the clinical efficacy and safety profile of Verzenio + endocrine therapy as adjuvant therapy after surgery for HR+/ HER2- lymph node-positive early breast cancer patients (N=5,637) at high risk of recurrence, compared to the existing standard endocrine therapy.

 

a clinical study The monarchE cohort 1, which served as the basis for domestic approval, included 5120 patients (91%).

 

The primary evaluation index was Invasive Disease-Free Survival (IDFS), and the secondary evaluation index was DRFS and OS.

 

Looking closely at the results, Verzenio + endocrine therapy in monarchE cohort 1 reduced the risk of recurrence and death by about 35% at 4 years compared to endocrine therapy alone.

 

The absolute difference of Verzenio gradually increased from 3.1% in the second year to 5.0% in the third year and 6.9% in the fourth year.

 

The risk of distant recurrence and death was also reduced by approximately 35%, and OS has not yet been derived.

 

Early breast cancer patients are treated with the goal of a complete cure, but in the case of recurrent or metastatic breast cancer patients, the goal is changed to treatment to prolong life and improve quality of life.

 

Since the risk of recurrence is highest in the first 1 to 2 years after diagnosis, treatment to prevent recurrence after surgery is essential.

 

About 14% to 23% of hormone receptor-positive (HR+) early breast cancer patients still experience recurrence even after surgery and endocrine therapy as an adjuvant treatment after surgery.

 

In particular, according to a real-world study conducted in the United States, patients with recurrence risk factors defined in the IDFS, monarchE study showed about three times greater recurrence risk than breast cancer patients who did not.

 

Among the risk factors for recurrence defined by monarchE, Cohort 1, the domestic approval standard, is ▲4 or more pALN, ▲1 to 3 positive axillary lymph nodes, and ▲ a tumor size of 5cm or more, ▲histological grade 3.

 

While there was an unmet demand for more effective treatment options for the high-risk group for recurrence in the early stage of breast cancer, Verzenio obtained significant results in HR+/HER2- lymph node-positive high-risk early breast cancer with high-risk recurrence through the phase 3 trial of monarchE in 2020.

 

And based on this, in November 2022, for the first time as a CDK4/6 inhibitor, it obtained approval from the Ministry of Food and Drug Safety in Korea as a combination therapy with endocrine therapy as an adjuvant treatment for adult patients with high-risk early breast cancer with HR+/HER2- positive lymph node recurrence.

 

Jihyung Kim, Professor of Oncology at Gangnam Severance Hospital, said, “As a strategy to lower the risk of recurrence in early breast cancer patients, the introduction of new adjuvant drug therapy after surgery can improve the patient’s long-term treatment prognosis as well as reduce the possibility of recurrence or metastatic breast cancer.

 

There are also benefits from the national fiscal perspective,” Kim said.

 

Kim emphasized, “We hope that more domestic early breast cancer patients at high risk of recurrence can enjoy the treatment benefits of Verzenio through the application of domestic health insurance benefits for Verzenio, which has shown clinical usefulness for early breast cancer patients at high risk of recurrence.”